Acute Myeloid Leukemia Clinical Trial

A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias

Summary

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A) or nucleophosmin 1 gene (NPM1) or nucleoporin (NUP98 or NUP214) alterations
Performance status greater than or equal to (>=) 50 by lansky scale (for participants less than [<] 16 years of age) or >=50 percent (%) karnofsky scale (for participants >=16 years of age)
Estimated or measured glomerular filtration rate >= 60 milliliter per minute per 1.73 meter square (mL/min/1.73m^2) based on the bed side schwartz formula

Exclusion Criteria:

Received an allogeneic hematopoietic transplant within 60 days of screening
Active acute graft-versus-host disease of any grade or chronic graft-versus-host which is not well-controlled
Received immunosuppressive therapy post hematopoietic transplant within 30 days of enrollment
Diagnosis of Down syndrome associated leukemia, acute promyelocytic leukemia, juvenile myelomonocytic leukemia
Diagnosis of fanconi anemia, kostmann syndrome, shwachman diamond syndrome, or any other known bone marrow failure syndrome
Prior exposure to menin-KMT2A inhibitors
Prior cancer immunotherapy (ie [that is], Chimeric Antigen Receptor-T Cell Therapy [CAR-T], inotuzumab, gemtuzumab ozogamicin) within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT05521087

Recruitment Status:

Not yet recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 31 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
City of Hope National Medical Center
Duarte California, 91010, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Memorial Sloan Kettering
New York New York, 10065, United States
UNC Hospitals - N.C. Childrens Hospital
Chapel Hill North Carolina, 27514, United States
Atrium Health
Charlotte North Carolina, 28203, United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
St Jude Children's Research Hospital
Memphis Tennessee, 38105, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Utah
Salt Lake City Utah, 84112, United States
Children's Wisconsin - Milwaukee Hospital
Milwaukee Wisconsin, 53226, United States
Hôpital Jeanne de Flandre
Lille , 59000, France
Institut D'Hematologie Et D'Oncologie Pediatrique
Lyon Cedex 08 , 69008, France
Hôpital trousseau- APHP
Paris , 75012, France
Hôpital Robert Debré
Paris , 75019, France
CHU de Rennes - Hôpital Sud
Rennes Cedex 2 , 35200, France
CHU de Toulouse Hopital des Enfants
Toulouse , 31300, France
Centre Hospitalier Universitaire de Nancy - Hôpital Central
Vandœuvre-lès-Nancy , 54500, France
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin , 12203, Germany
Universitatsklinikum Essen
Essen , 45147, Germany
Universitaetsklinik Hamburg-Eppendorf
Hamburg , 20246, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Dr. Von Haunersches Kinderspital der Universitaet Muenchen
Munchen , 80337, Germany
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Infantil Univ. Niño Jesus
Madrid , 28009, Spain
Hosp. Univ. Miguel Servet
Zaragoza , 50009, Spain
Birmingham Children's Hospital
Birmingham , B4 6N, United Kingdom
Royal Hospital for Sick Children
Glasgow , G51 4, United Kingdom
University College London Hospitals
London , NW1 2, United Kingdom
Great Ormond Street Hospital
London , WC1N , United Kingdom
Royal Marsden Hospital
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT05521087

Recruitment Status:

Not yet recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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